Ismar Soluciones Dinámicas S de RL de CV Warning Letter Details

Summary

Ismar Soluciones Dinámicas S de RL de CV, a Mexican drug manufacturer, was cited for manufacturing OZÓ HAND SANITIZER, an unapproved antiseptic hand sanitizer product that was adulterated and misbranded in violation of federal law. FDA laboratory testing of a batch detained at the U.S. border found that the product did not contain the labeled 70% ethyl alcohol concentration, constituting adulteration under sections 501(d)(2) and 501(a)(2)(B) of the FD&C Act and demonstrating failures in the company's quality assurance and Current Good Manufacturing Practice (CGMP) compliance. The product also violated regulations as an unapproved new drug introduced into interstate commerce and was misbranded under multiple sections of the FD&C Act, leading to its detention and refusal of admission at the border.